Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-27 @ 8:16 PM
Study NCT ID:
NCT01892904
Status:
COMPLETED
Last Update Posted:
2015-09-09
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-08', 'studyFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days with dysmenorrheic pain over 140 days of evaluation period', 'timeFrame': 'Evaluation period which starts on 25th day after start of treatment and lasts for 140 days', 'description': 'Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.'}], 'secondaryOutcomes': [{'measure': 'Change in Dysmenorrhea score from baseline to period of withdrawal bleeding', 'timeFrame': 'Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days', 'description': 'Dysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visit'}, {'measure': 'Change of severity of pain Description', 'timeFrame': 'Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days', 'description': 'The severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit.'}, {'measure': 'Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period', 'timeFrame': 'Evaluation period which starts on 25th day after start of treatment and lasts for 140 days', 'description': 'Number of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary.'}, {'measure': 'Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period', 'timeFrame': 'Evaluation period which starts on 25th day after start of treatment and lasts for 140 days', 'description': 'Number of days with rescue medicine is determined based on daily record of Patient Diary.'}, {'measure': 'Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period', 'timeFrame': 'Evaluation period which starts on 25th day after start of treatment and lasts for 140 days', 'description': 'Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary'}, {'measure': 'Endometrial thickness', 'timeFrame': '24 weeks after taking the initial study medication', 'description': 'Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.'}, {'measure': 'Number of days with bleeding and spotting over treatment phase', 'timeFrame': 'Up to 24 weeks', 'description': 'Number of days with spotting/bleeding is determined based on daily record of Patient Diary.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['YAZ', 'Flexible regimen', 'Drospirenone', 'Ethinylestradiol Betadex', 'Dysmenorrhea', 'Japanese patients'], 'conditions': ['Dysmenorrhea']}, 'referencesModule': {'references': [{'pmid': '32210639', 'type': 'DERIVED', 'citation': 'Momoeda M, Akiyama S, Yamamoto S, Kondo M, Fukai T. Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study. Int J Womens Health. 2020 Mar 10;12:175-185. doi: 10.2147/IJWH.S242864. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative study (24-week treatment period).\n\nThe objective of this study is to prove the superiority of BAY 86-5300 with flexible extended regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation period.\n\nIn addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients treated for one year will be investigated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Dysmenorrhea patients with a total dysmenorrhea score (sum of the two sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of the last two menstruations before randomization (baseline observation phase)\n\n* Patients with dysmenorrheic pain during the 2 baseline cycles before randomization. Dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with possible radiation towards back or thighs recorded in the Patient Diary in correspondence with a withdrawal and/or menstrual bleeding episode. Pain could start up to 2 days before the onset of the bleeding episode the bleeding and terminates on the last day of bleeding of before\n* Patients having the regular cyclic menstrual period (25 to 38 days) in the latest two menses before randomization (baseline observation phase)\n* Willingness to use a barrier method (i.e., non-hormonal method) for contraception during the study. Acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device.\n\nExclusion Criteria: - Patients who have organic diseases of which surgical treatment is prioritized by the investigator\n\n* Patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in size of the longest diameters\n* Patients with ovarian chocolate cysts having solid part in the cyst\n* Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)'}, 'identificationModule': {'nctId': 'NCT01892904', 'briefTitle': 'Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of a Flexible Extended Regimen of BAY 86-5300 (0.02 mg Ethinylestradiol [β-CDC] and 3 mg Drospirenone) Compared to the 28-day (24 + 4-day) Regimen of BAY 86-5300 in the Treatment of Dysmenorrhea for 24 Weeks', 'orgStudyIdInfo': {'id': '16114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EE20/DRSP(BAY86-5300)-flexibel extended regimen', 'description': 'One tablet \\[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\\] / day with flexible extended regimen (24-day to 120-day active tablet intake followed by 4-day tablet free interval)', 'interventionNames': ['Drug: EE20/DRSP(BAY86-5300)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EE20/DRSP(BAY86-5300)-28 days cyclic regimen', 'description': 'One tablet \\[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\\] / day with 28-day cyclic regimen (24-day active tablet intake followed by 4-day placebo tablet intake)', 'interventionNames': ['Drug: EE20/DRSP(BAY86-5300)']}], 'interventions': [{'name': 'EE20/DRSP(BAY86-5300)', 'type': 'DRUG', 'description': 'One tablet \\[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\\] / day', 'armGroupLabels': ['EE20/DRSP(BAY86-5300)-28 days cyclic regimen', 'EE20/DRSP(BAY86-5300)-flexibel extended regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '270-2267', 'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'zip': '530-0013', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '542-0086', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '192-0046', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '108-0071', 'city': 'Minato', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6581, 'lon': 139.7515}}, {'zip': '157-0066', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '167-0051', 'city': 'Suginami-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '171-0021', 'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}